FDA 510(k)

VitaVitro® 繁殖培養基，VitaVitro® 精子緩冲培養基，VitaVitro® 淨化緩冲培養基

K 號：K200408 · 2020-10-16

決定日期2020-10-16

產品代碼MQL

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K200408. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K200408.

When did VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium receive FDA 510(k) clearance?

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium received FDA 510(k) clearance on 2020-10-16, under 510(k) number K200408.

Who is the listed applicant for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

The FDA 510(k) record lists Shenzhen Vitavitro Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

The FDA product code for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium is MQL.

其他以 Shenzhen Vitavitro Biotech Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K240523VitaVitro®單腔卵母細胞採集針（ORNS-17G、ORNS-18G），VitaVitro®雙腔卵母細胞採集針（ORND-17G）K240307VitaVitro 胚胎移植針管（型號 ET-S、ET-SI、ET-A、ET-I、ET-IH）K212410VitaVitro 精子洗滌劑，VitaVitro 精子濾層劑 K1910631-步驟培養基質

相關器械（代碼：MQL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254261凍結凈化組合包及融解組合包（CS-IVF-FK；CS-IVF-TK）CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248超快速加熱Kitazato Corporation K252672CaseBio™ 綠色培養液/含人血清白蛋白 (CMH5)；CaseBio™ 操控/含人血清白蛋白 (WHH5)Casebioscience, Inc.K250445快速加熱 - NXFujifilm Irvine Scientific K251637Dewin生殖培養基（Dewin配子緩衝液[含HSA和不含HSA]；Dewin卵泡沖洗液，Dewin一步培養基[含HSA和不含HSA]）Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305超快速玻化器；超快速加熱器Kitazato Corporation

官方來源

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